Recurrent Laryngeal CarcinomaNCT03604601
Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma
An observational study of Recurrent Laryngeal Carcinoma, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Early laryngeal cancer can be treatment by laser surgery or radiotherapy, intermediate and advanced laryngeal carcinoma mainly surgical treatment. Laryngeal cancer is at risk of recurrence after treatment, whether in surgery, laser or radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Laryngeal Carcinoma
- What is being tested?
- salvage surgery
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with recurrent laryngeal squamous cell carcinoma
Who may be able to join
- more than 18 years,
- patients with recurrent glottic laryngeal squamous cell carcinoma undergoing salvage surgery
Who cannot join
- postoperative radiotherapy and chemotherapy
- loss to follow-up
About this study
Official title: Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma: A Single-institutional Experience
Early laryngeal cancer can be treatment by laser surgery or radiotherapy, intermediate and advanced laryngeal carcinoma mainly surgical treatment. Laryngeal cancer is at risk of recurrence after treatment, whether in surgery, laser or radiotherapy. The recurrence rate of laryngeal cancer is about 10% reported at home and abroad. Local pain, ulcers, breathing and eating difficulties caused by recurrent laryngeal cancer seriously reduce the quality of life of patients and seriously endanger their lives. Therefore, head and neck surgeons are required to make every effort to give them saving treatment in order to improve their quality of life. Prolong the patient's life.
Read the detailed description
medical records and extracted information including age, gender, initial treatment modality of glottis cancer, recurrence time, recurrence site, histopathology, tumor grade according to World Health Organization (WHO) grade and tumor stage. Stages were defined according to the American Joint Committee on Cancer (AJCC) staging system.
- Conditions
- Recurrent Laryngeal Carcinoma
- Being tested
- salvage surgery
- Keywords
- salvage surgery, recurrent laryngeal carcinoma, experience
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salvage surgeryProcedure or surgery
Salvage surgery hopes to control the recurrence of larynx, pharynx, fistula and neck tumor and improve the quality of life and survival rate
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
The overall survival rate was calculated with Kaplan-Meier method.
Measured: Follow up 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Jun 2016
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Laryngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GengLong Liu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Genglong Liu, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604601
- Sponsor's protocol ID
- recurrent laryngeal carcinoma
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma: A Single-institutional Experience
- ClinicalTrials.gov ID
- NCT03604601
- Acronym / sponsor ID
- recurrent laryngeal carcinoma
- Conditions
- Recurrent Laryngeal Carcinoma
- Keywords
- salvage surgery, recurrent laryngeal carcinoma, experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early laryngeal cancer can be treatment by laser surgery or radiotherapy, intermediate and advanced laryngeal carcinoma mainly surgical treatment. Laryngeal cancer is at risk of recurrence after treatment, whether in surgery, laser or radiotherapy. The recurrence rate of laryngeal cancer is about 10% reported at home and abroad. Local pain, ulcers, breathing and eating difficulties caused by recurrent laryngeal cancer seriously reduce the quality of life of patients and seriously endanger their lives. Therefore, head and neck surgeons are required to make every effort to give them saving treatment in order to improve their quality of life. Prolong the patient's life.
Detailed description
medical records and extracted information including age, gender, initial treatment modality of glottis cancer, recurrence time, recurrence site, histopathology, tumor grade according to World Health Organization (WHO) grade and tumor stage. Stages were defined according to the American Joint Committee on Cancer (AJCC) staging system.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with recurrent laryngeal squamous cell carcinoma
Key inclusion criteria (2 listed)
- more than 18 years,
- patients with recurrent glottic laryngeal squamous cell carcinoma undergoing salvage surgery
Key exclusion criteria (2 listed)
- postoperative radiotherapy and chemotherapy
- loss to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salvage surgerySalvage surgery hopes to control the recurrence of larynx, pharynx, fistula and neck tumor and improve the quality of life and survival rate | Procedure or surgery | – |
Primary outcome
overall survival (OS)
Time frame: Follow up 5 years
The overall survival rate was calculated with Kaplan-Meier method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Genglong Liu principal investigator
First Affiliated Hospital, Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Laryngeal Carcinoma, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: Follow up 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.